Intraductal temperature-controlled radiofrequency ablation in malignant hilar obstruction: a preliminary study in animals and initial human experience

Abstract

Background and study aims Intraductal radiofrequency ablation (ID-RFA) is a recently developed method widely used for treatment of malignant extrahepatic biliary tract obstructions. However, its safety in hilar application has yet to be clearly demonstrated. The aim of this study was to evaluate the safety of ID-RFA in the treatment of malignant hilar obstruction.

Patients and methods Endoscopic retrograde cholangiography followed by temperature-controlled ID-RFA at the hilar area using different probe lengths (11, 18, and 22 mm) and settings (7 or 10 W for 60 – 120 s) was performed in six mini-pigs. In addition, patients with malignant hilar obstruction who underwent palliative ID-RFA were retrospectively evaluated.

Results In the animal study using different ID-RFA settings, post-ID-RFA fluoroscopic radiocontrast leakage and microscopic bile duct perforation with hepatic abscess were observed in four of the six mini-pigs. Only two of the them, in which an 11-mm ID-RFA probe at a target temperature of 80 °C, power of 7 W, and duration of 60 s was used, underwent successful ID-RFA without any immediate adverse events (AEs). Clinically, ID-RFA was performed using the 11-mm probe with the setting of 80 °C, 7 W, and 60 – 120 s for malignant hilar obstruction, and total of 11 patients underwent successful ID-RFA without AEs.

Conclusions Our study suggests that ID-RFA performed using a short-length probe with settings of 80 °C, 7 W and 60 – 120 s is a safe and feasible palliative treatment for malignant hilar obstruction.

• References

• 1 Laquiere A, Boustiere C, Leblanc S. et al. Safety and feasibility of endoscopic biliary radiofrequency ablation treatment of extrahepatic cholangiocarcinoma. Surg Endosc 2016; 30: 1242-1248
• 2 Zheng X, Bo ZY, Wan W. et al. Endoscopic radiofrequency ablation may be preferable in the management of malignant biliary obstruction: A systematic review and meta-analysis. J Dig Dis 2016; 17: 716-724
• 3 Steel AW, Postgate AJ, Khorsandi S. et al. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc 2011; 73: 149-153
• 4 Yang J, Wang J, Zhou H. et al. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy 2018; 50: 751-760
• 5 Teoh AY, Cheung SY, Chong C. et al. Endoscopic biliary radiofrequency ablation for malignant distal common bile duct strictures does not improve survival. A randomized controlled trial. Gastrointestinal Endoscopy 2018; 87: AB104-AB105
• 6 Wang J, Zhao L, Zhou C. et al. Percutaneous intraductal radiofrequency ablation combined with biliary stent placement for nonresectable malignant biliary obstruction improves stent patency but not survival. Medicine (Baltimore) 2016; 95: e3329
• 7 Camus M, Napoleon B, Vienne A. et al. Efficacy and safety of endobiliary radiofrequency ablation for the eradication of residual neoplasia after endoscopic papillectomy: a multicenter prospective study. Gastrointest Endosc 2018; 88: 511-518
• 8 Schmidt A, Bloechinger M, Weber A. et al. Short-term effects and adverse events of endoscopically applied radiofrequency ablation appear to be comparable with photodynamic therapy in hilar cholangiocarcinoma. United European Gastroenterol J 2016; 4: 570-579
• 9 Strand DS, Cosgrove ND, Patrie JT. et al. ERCP-directed radiofrequency ablation and photodynamic therapy are associated with comparable survival in the treatment of unresectable cholangiocarcinoma. Gastrointest Endosc 2014; 80: 794-804
• 10 Zhou C, Wei B, Gao K. et al. Biliary tract perforation following percutaneous endobiliary radiofrequency ablation: A report of two cases. Oncol Lett 2016; 11: 3813-3816
• 11 Dolak W, Schreiber F, Schwaighofer H. et al. Endoscopic radiofrequency ablation for malignant biliary obstruction: a nationwide retrospective study of 84 consecutive applications. Surg Endosc 2014; 28: 854-860
• 12 Tal AO, Vermehren J, Friedrich-Rust M. et al. Intraductal endoscopic radiofrequency ablation for the treatment of hilar non-resectable malignant bile duct obstruction. World J Gastrointest Endosc 2014; 6: 13-19
• 13 Topazian M, Levy MJ, Patel S. et al. Hepatic artery pseudoaneurysm formation following intraductal biliary radiofrequency ablation. Endoscopy 2013; 45 (Suppl. 02) E161-162
• 14 Wang Y, Cui W, Fan W. et al. Percutaneous intraductal radiofrequency ablation in the management of unresectable Bismuth types III and IV hilar cholangiocarcinoma. Oncotarget 2016; 7: 53911-53920
• 15 Wu TT, Li HC, Li WM. et al. percutaneous intraluminal radiofrequency ablation for malignant extrahepatic biliary obstruction: a safe and feasible method. Dig Dis Sci 2015; 60: 2158-2163
• 16 Wadsworth CA, Westaby D, Khan SA. Endoscopic radiofrequency ablation for cholangiocarcinoma. Curr Opin Gastroenterol 2013; 29: 305-311
• 17 Cho JH, Lee KH, Kim JM. et al. Safety and effectiveness of endobiliary radiofrequency ablation according to the different power and target temperature in a swine model. J Gastroenterol Hepatol 2017; 32: 521-526
• 18 Barret M, Leblanc S, Vienne A. et al. Optimization of the generator settings for endobiliary radiofrequency ablation. World J Gastrointest Endosc 2015; 7: 1222-1229
• 19 Kim EJ, Chung DH, Kim YJ. et al. Endobiliary radiofrequency ablation for distal extrahepatic cholangiocarcinoma: A clinicopathological study. PLoS One 2018; 13: e0206694
• 20 Castaing D. Surgical anatomy of the biliary tract. HPB (Oxford) 2008; 10: 72-76
• 21 Cho JH, Jeong S, Kim EJ. et al. Long-term results of temperature-controlled endobiliary radiofrequency ablation in a normal swine model. Gastrointest Endosc 2018; 87: 1147-1150
• 22 Anderson MA, Fisher L. ASGE Standards of Practice Committee. et al. Complications of ERCP. Gastrointest Endosc 2012; 75: 467-473
• 23 Sofi AA, Khan MA, Das A. et al. Radiofrequency ablation combined with biliary stent placement versus stent placement alone for malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc 2018; 87: 944-951 e941